Products12
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1817Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 175 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1803Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 50 ug in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1809Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 100 ug in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1823Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 137 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1819Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 200 ug in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1821Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 300 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1811Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 112 ug in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1805Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 75 ug in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1800Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 25 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Levothyroxine Sodium
Product Details
NDC Product Code
0378-1807Application Number
ANDA076187Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2020BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 88 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
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